FDA Adverse Event
Malfunction
Summary report: N
EXTRACTOR RX RETRIEVAL BALLOON
MDR report key: 1081537
·
Received July 25, 2008
Report
- Report Number
- 3005099803-2008-01303
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Report Date
- June 30, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORK LTD
- Product Code
- FGE
- PMA / PMN Number
- K970052
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE, THE BALLOON DETACHED FROM THE CATHETER. DURING AN ERCP PROCEDURE IN THE COMMON BILE DUCT, THE EXTRACTOR BALLOON DETACHED FROM THE CATHETER WHEN THE CATHETER WAS REMOVED FROM THE PT. THE BALLOON WAS LEFT IN THE SMALL BOWEL TO PASS ON IT'S OWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR BALLOON. THERE WERE NO PT COMPLICATIONS AND THE PT WAS REPORTED TO BE FINE POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTRACTOR RX RETRIEVAL BALLOON | FGE - BILIARY STONE RETRIEVAL BALLOON CATHETER | FGE | BOSTON SCIENTIFIC CORK LTD | M00546950 | 11414885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |